Type 2 Diabetes MellitusPhase 3NCT00110435
A Multicenter Study to Evaluate the Cholesterol Lowering Effects of Two Marketed Products in Patients With Type 2 Diabetes Mellitus and Hypercholesterolemia (MK-0653A-077)
A Phase 3 study testing MK0653A, ezetimibe (+) simvastatin and Comparator: atorvastatin in people with Type 2 Diabetes Mellitus and Hypercholesterolemia, run by Organon and Co.
Trial summary
The purpose of this 10-week study is to compare the reduction in cholesterol following treatment with two different marketed drugs, in patients with type 2 diabetes mellitus and hypercholesterolemia. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Type 2 Diabetes Mellitus, Hypercholesterolemia
- What is being tested?
- MK0653A, ezetimibe (+) simvastatin and Comparator: atorvastatin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,229 participants
- Where
- No sites listed yet
- Study dates
- May 2005to Dec 2005
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women aged 18 to 79 years who have a confirmed diagnosis of type 2 diabetes mellitus with elevated cholesterol levels may be eligible to participate in a study to assess the efficacy and safety of the two marketed drugs.
Who cannot join
- Type 1 Diabetes Mellitus
- Type 2 Diabetes Mellitus that is poorly controlled
About this study
Official title: A Multicenter, Randomized, Double-blind, Parallel Group, 6-Week Study to Evaluate the Efficacy and Safety of Ezetimibe/Simvastatin Combination Tablet Versus Atorvastatin in Patients With Type 2 Diabetes Mellitus (T2DM) and Hypercholesterolemia
The purpose of this 10-week study is to compare the reduction in cholesterol following treatment with two different marketed drugs, in patients with type 2 diabetes mellitus and hypercholesterolemia.
- Conditions
- Type 2 Diabetes Mellitus, Hypercholesterolemia
- Being tested
- MK0653A, ezetimibe (+) simvastatin, Duration of Treatment: 4 wk placebo run in then 6 wk active, Comparator: atorvastatin
- Medical subject headings
- Diabetes Mellitus, Type 2, Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MK0653A, ezetimibe (+) simvastatinDrug
Duration of Treatment: 4 wk placebo run in then 6 wk activeDrug
Comparator: atorvastatinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent reduction in LDL-C from baseline after 6 weeks of treatment
Secondary outcomes (1)
Percent of patients attaining LDL-C <70 mg/dl after 6 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2005 (estimated)
- Study startMay 2005
- Primary completionDec 2005
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,229 participants (actual)
Sponsor and investigators
- Lead sponsor
- Organon and Co
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00110435
- Sponsor's protocol ID
- 0653A-077
- Other IDs
- MK0653A-077, 2005_022
- Status last verified
- Feb 2022
- First submitted
- 9 May 2005
- Last updated
- 15 Aug 2024
- Results posted
- No
Publications
Goldberg RB, Guyton JR, Mazzone T, Weinstock RS, Polis A, Edwards P, Tomassini JE, Tershakovec AM. Ezetimibe/simvastatin vs atorvastatin in patients with type 2 diabetes mellitus and hypercholesterolemia: the VYTAL study. Mayo Clin Proc. 2006 Dec;81(12):1579-88. doi: 10.4065/81.12.1579.
PubMed 17165637Tomassini JE, Mazzone T, Goldberg RB, Guyton JR, Weinstock RS, Polis A, Jensen E, Tershakovec AM. Effect of ezetimibe/simvastatin compared with atorvastatin on lipoprotein subclasses in patients with type 2 diabetes and hypercholesterolaemia. Diabetes Obes Metab. 2009 Sep;11(9):855-64. doi: 10.1111/j.1463-1326.2009.01061.x. Epub 2009 Jun 5.
PubMed 19508464
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Parallel Group, 6-Week Study to Evaluate the Efficacy and Safety of Ezetimibe/Simvastatin Combination Tablet Versus Atorvastatin in Patients With Type 2 Diabetes Mellitus (T2DM) and Hypercholesterolemia
- ClinicalTrials.gov ID
- NCT00110435
- Acronym / sponsor ID
- 0653A-077
- Conditions
- Type 2 Diabetes Mellitus, Hypercholesterolemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,229 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- May 2005
- Primary completion
- Dec 2005 (actual)
- Study completion
- Dec 2005 (actual)
- First posted
- 10 May 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this 10-week study is to compare the reduction in cholesterol following treatment with two different marketed drugs, in patients with type 2 diabetes mellitus and hypercholesterolemia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Men and women aged 18 to 79 years who have a confirmed diagnosis of type 2 diabetes mellitus with elevated cholesterol levels may be eligible to participate in a study to assess the efficacy and safety of the two marketed drugs.
Key exclusion criteria (2 listed)
- Type 1 Diabetes Mellitus
- Type 2 Diabetes Mellitus that is poorly controlled
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MK0653A, ezetimibe (+) simvastatin | Drug | – |
| Duration of Treatment: 4 wk placebo run in then 6 wk active | Drug | – |
| Comparator: atorvastatin | Drug | – |
Primary outcome
Percent reduction in LDL-C from baseline after 6 weeks of treatment
1 secondary outcome
Percent of patients attaining LDL-C <70 mg/dl after 6 weeks of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2024.
- Background: PubMed 17165637Goldberg RB, Guyton JR, Mazzone T, Weinstock RS, Polis A, Edwards P, Tomassini JE, Tershakovec AM. Ezetimibe/simvastatin vs atorvastatin in patients with type 2 diabetes mellitus and hypercholesterolemia: the VYTAL study. Mayo Clin Proc. 2006 Dec;81(12):1579-88. doi: 10.4065/81.12.1579.
- Background: PubMed 19508464Tomassini JE, Mazzone T, Goldberg RB, Guyton JR, Weinstock RS, Polis A, Jensen E, Tershakovec AM. Effect of ezetimibe/simvastatin compared with atorvastatin on lipoprotein subclasses in patients with type 2 diabetes and hypercholesterolaemia. Diabetes Obes Metab. 2009 Sep;11(9):855-64. doi: 10.1111/j.1463-1326.2009.01061.x. Epub 2009 Jun 5.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Monitor study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing MK0653A, ezetimibe (+) simvastatin and Comparator: atorvastatin in people with Type 2 Diabetes Mellitus and Hypercholesterolemia, run by Organon and Co.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent reduction in LDL-C from baseline after 6 weeks of treatment. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00110435, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2024.